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Table 3 Factors explaining the mean (±standard deviation) of the standardized differences in superiority and noninferiority trials and single p-value after adjustment on the type of trial.

From: What differences are detected by superiority trials or ruled out by noninferiority trials? A cross-sectional study on a random sample of two-hundred two-arms parallel group randomized clinical trials

 

Superiority trials

Noninferiority trials

P-value*

 

Standardized

difference

No.

P-value

Standardized

difference

No.

P-value

 

Year of publication

       

   2004-2006

0.46 (0.23)

59

0.42

0.28 (0.13)

59

0.40

0.72

   2007-2009

0.42 (0.30)

41

-

0.30 (0.12)

41

-

-

Medical context

  

0.38

  

0.001

0.006

   Cardiovascular

0.36 (0.22)

14

 

0.18 (0.09)

19

  

   Infectious diseases

0.51 (0.11)

3

 

0.33 (0.08)

23

  

   Oncology

0.44 (0.23)

6

 

0.26 (0.008)

10

  

   Other

0.47 (0.27)

77

 

0.31 (0.14)

48

  

Pharmacological trial

       

   Yes

0.44 (0.28)

54

0.76

0.29 (0.12)

73

0.99

0.77

   No (other area)

0.46 (0.24)

46

-

0.29 (0.15)

27

-

-

Patients age-group

  

0.43

   

0.46

   Children < 18 yrs

0.51 (0.18)

18

 

0.31 (0.10)

18

0.41

 

   Adults

0.44 (0.28)

77

 

0.28 (0.13)

82

-

 

   Elderly

0.35 (0.13)

5

 

-

0

-

 

Mortality outcome

       

   Yes

0.28 (0.17)

11

0.02

0.17 (0.09)

17

<0.001

<0.001

   No

0.47 (0.26)

89

-

0.31 (0.12)

83

-

-

Statistician involved

       

   Yes

0.44 (0.27)

46

0.83

0.28 (0.14)

54

0.64

0.69

   No

0.45 (0.26)

54

-

0.29 (0.10)

46

-

-

Patients' recruitment

       

   Multicenter

0.38 (0.21)

67

<0.001

0.28 (0.12)

88

0.02

<0.001

   Single-center

0.58 (0.30)

33

-

0.36 (0.16)

12

-

-

Funding source

  

0.18

  

0.95

0.19

   Industry

0.40 (0.22)

50

 

0.29 (0.12)

70

  

   Institution/private

0.47 (0.32)

33

 

0.28 (0.14)

25

  

   Not reported/funded

0.53 (0.23)

17

 

0.29 (0.09)

5

  

Sample size ≤200

0.67 (0.25) 0.42 (0.10)

37 27

 

0.38 (0.13) 0.36 (0.09)

10 23

  

   200-400

0.28 (0.07)

14

<0.001

0.28 (0.09)

38

<0.001

**

   400-800

0.18 (0.13)

20

 

0.20 (0.14)

28

  

   >800

       
  1. *P-value for each factor after adjustment on the type of trial. **There was a significant interaction between superiority/noninferiority type of the trial and sample size.